Managing anticoagulation in patients with benign prostatic hyperplasia undergoing laser surgery
Multicenter Randomized Open-labelled Trial Which Aims to Show Non-inferiority of Adverse Events Risk During the Maintenance of Oral-anticoagulation in the Surgery of Benign Prostatic Hypertrophy by Laser Photovaporization
NA · Clinique Pasteur · NCT03297281
This study is testing whether keeping patients on blood thinners or stopping them before laser surgery for prostate enlargement is safer and leads to fewer complications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 389 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Clinique Pasteur (other) |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT03297281 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of maintaining or discontinuing oral anticoagulation (OAC) in patients undergoing photovaporization of the prostate (PVP) for benign prostatic hyperplasia (BPH). It is a multicentric, open-label, non-inferiority trial with two parallel arms, comparing outcomes between patients who continue OAC and those who stop it before surgery. The goal is to improve perioperative management and reduce complications associated with anticoagulation during BPH surgery.
Who should consider this trial
Good fit: Ideal candidates are men with benign prostatic hyperplasia who are experiencing micturition disorders resistant to medical treatment and are on long-term anticoagulation therapy.
Not a fit: Patients with a history of prostate cancer, previous pelvic radiotherapy, or those on injectable anticoagulant therapy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety of surgical procedures for patients on anticoagulation therapy, potentially reducing complications and improving outcomes.
How similar studies have performed: Other studies have explored anticoagulation management in surgical settings, but this specific approach to BPH surgery with PVP is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Prostate volume \< or = 30 gr * Micturition disorders resistant to medical treatment related to HBP and/or complications related to BPH (retention, lithiasis...) * Patient candidate for photovaporization of the prostate * Patient under treatment AVK (Anti Vitamin K) for more than 3 months with an objective of INR (International Normalized Ratio) between 2 and 3 or patient under DOACs (Direct Oral Anti-coagulants) for more than 3 months * Unprotected major * Patient affiliated to a social security scheme or equivalent * Patient is willing and able to comply with all study requirements and to sign a study-specific informed consent form. Exclusion Criteria: * History of prostate cancer * Previous pelvic radiotherapy * History of stenosis of the urethra * Patient with one or more bladder polyps * Patient under antiplatelet agent other than aspirin * Allergy to heparin or history of heparin-induced thrombocytopenia * Patients under anticoagulant injectable therapy at baseline (heparin, LMWH (Low Molecular Weight Heparin), fondaparinux) * Any mechanical prosthetic heart valve * Stroke (ischemic or hemorrhagic), systemic embolism or transient ischemic attack within past 12 weeks * Venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) within past 12 weeks * Major bleeding within past 6 weeks * Severe renal insufficiency (calculated creatinine clearance \< 30 mL / min) * Thrombocytopenia (platelet count \< 100 x 10\^9 / L) * Life expectancy \< 1 month * Condition that impairs compliance with trial protocol (e.g. cognitive impairment, uncontrolled psychiatric condition, geographic inaccessibility) * Contra-indication to PVP surgery or contra-indication to general anesthesia * Protected patients : majors under some form of guardianship * Patient participating in another clinical study
Where this trial is running
Toulouse
- Clinique Pasteur — Toulouse, France (RECRUITING)
Study contacts
- Principal investigator: Vincent Misrai, Dr — Clinique Pasteur
- Study coordinator: Vincent Misraï, Dr
- Email: vmisrai@clinique-pasteur.com
- Phone: 05 62 21 33 26
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Benign Prostatic Hyperplasia, Anticoagulant Adverse Reaction, Photovaporization, Laser, Benign prostatic hyperplasia, Oral anticoagulation, Complication